EP4233720A3 - Medizinische vorrichtung zur detektion von mindestens einem analyten in einer körperflüssigkeit - Google Patents

Medizinische vorrichtung zur detektion von mindestens einem analyten in einer körperflüssigkeit Download PDF

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Publication number
EP4233720A3
EP4233720A3 EP23175598.4A EP23175598A EP4233720A3 EP 4233720 A3 EP4233720 A3 EP 4233720A3 EP 23175598 A EP23175598 A EP 23175598A EP 4233720 A3 EP4233720 A3 EP 4233720A3
Authority
EP
European Patent Office
Prior art keywords
analyte
medical device
analyte sensor
sensor
housing
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP23175598.4A
Other languages
English (en)
French (fr)
Other versions
EP4233720A2 (de
EP4233720B1 (de
Inventor
Helmut Walter
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
F Hoffmann La Roche AG
Roche Diabetes Care GmbH
Original Assignee
F Hoffmann La Roche AG
Roche Diabetes Care GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by F Hoffmann La Roche AG, Roche Diabetes Care GmbH filed Critical F Hoffmann La Roche AG
Priority to FIEP23175598.4T priority Critical patent/FI4233720T3/fi
Priority to PT231755984T priority patent/PT4233720T/pt
Priority to EP23175598.4A priority patent/EP4233720B1/de
Priority to LTEP23175598.4T priority patent/LT4233720T/lt
Priority to DK23175598.4T priority patent/DK4233720T3/da
Publication of EP4233720A2 publication Critical patent/EP4233720A2/de
Publication of EP4233720A3 publication Critical patent/EP4233720A3/de
Application granted granted Critical
Publication of EP4233720B1 publication Critical patent/EP4233720B1/de
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1468Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • A61B5/1473Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6848Needles
    • A61B5/6849Needles in combination with a needle set
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14503Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14546Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring analytes not otherwise provided for, e.g. ions, cytochromes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1486Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase
    • A61B5/14865Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B08CLEANING
    • B08BCLEANING IN GENERAL; PREVENTION OF FOULING IN GENERAL
    • B08B5/00Cleaning by methods involving the use of air flow or gas flow
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B08CLEANING
    • B08BCLEANING IN GENERAL; PREVENTION OF FOULING IN GENERAL
    • B08B7/00Cleaning by methods not provided for in a single other subclass or a single group in this subclass
    • B08B7/0035Cleaning by methods not provided for in a single other subclass or a single group in this subclass by radiant energy, e.g. UV, laser, light beam or the like
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/06Accessories for medical measuring apparatus
    • A61B2560/063Devices specially adapted for delivering implantable medical measuring apparatus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/16Details of sensor housings or probes; Details of structural supports for sensors
    • A61B2562/166Details of sensor housings or probes; Details of structural supports for sensors the sensor is mounted on a specially adapted printed circuit board
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/24Hygienic packaging for medical sensors; Maintaining apparatus for sensor hygiene
    • A61B2562/242Packaging, i.e. for packaging the sensor or apparatus before use
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6879Means for maintaining contact with the body
    • A61B5/688Means for maintaining contact with the body using adhesives

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pathology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Optics & Photonics (AREA)
  • Emergency Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
EP23175598.4A 2016-02-05 2016-02-05 Medizinische vorrichtung zur detektion von mindestens einem analyten in einer körperflüssigkeit Active EP4233720B1 (de)

Priority Applications (5)

Application Number Priority Date Filing Date Title
FIEP23175598.4T FI4233720T3 (fi) 2016-02-05 2016-02-05 Lääkinnällinen laite ainakin yhden analyytin havaitsemiseksi kehon nesteestä
PT231755984T PT4233720T (pt) 2016-02-05 2016-02-05 Dispositivo médico para deteção de pelo menos um analito num fluido corporal
EP23175598.4A EP4233720B1 (de) 2016-02-05 2016-02-05 Medizinische vorrichtung zur detektion von mindestens einem analyten in einer körperflüssigkeit
LTEP23175598.4T LT4233720T (lt) 2016-02-05 2016-02-05 Medicinos prietaisas, skirtas bent vienai medžiagai kūno skystyje aptikti
DK23175598.4T DK4233720T3 (da) 2016-02-05 2016-02-05 Medicinsk anordning til påvisning af mindst én analyt i en kropsvæske

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP21175139.1A EP3909506B1 (de) 2016-02-05 2016-02-05 Medizinische vorrichtung zur detektion von mindestens einem analyten in einer körperflüssigkeit
EP23175598.4A EP4233720B1 (de) 2016-02-05 2016-02-05 Medizinische vorrichtung zur detektion von mindestens einem analyten in einer körperflüssigkeit
EP16154468.9A EP3202323B1 (de) 2016-02-05 2016-02-05 Medizinische vorrichtung zur detektion von mindestens einem analyten in einer körperflüssigkeit

Related Parent Applications (2)

Application Number Title Priority Date Filing Date
EP16154468.9A Division EP3202323B1 (de) 2016-02-05 2016-02-05 Medizinische vorrichtung zur detektion von mindestens einem analyten in einer körperflüssigkeit
EP21175139.1A Division EP3909506B1 (de) 2016-02-05 2016-02-05 Medizinische vorrichtung zur detektion von mindestens einem analyten in einer körperflüssigkeit

Publications (3)

Publication Number Publication Date
EP4233720A2 EP4233720A2 (de) 2023-08-30
EP4233720A3 true EP4233720A3 (de) 2023-09-06
EP4233720B1 EP4233720B1 (de) 2024-07-17

Family

ID=55349656

Family Applications (5)

Application Number Title Priority Date Filing Date
EP21175139.1A Active EP3909506B1 (de) 2016-02-05 2016-02-05 Medizinische vorrichtung zur detektion von mindestens einem analyten in einer körperflüssigkeit
EP16154468.9A Active EP3202323B1 (de) 2016-02-05 2016-02-05 Medizinische vorrichtung zur detektion von mindestens einem analyten in einer körperflüssigkeit
EP23175609.9A Active EP4233721B1 (de) 2016-02-05 2016-02-05 Medizinische vorrichtung zur detektion von mindestens einem analyten in einer körperflüssigkeit
EP23175598.4A Active EP4233720B1 (de) 2016-02-05 2016-02-05 Medizinische vorrichtung zur detektion von mindestens einem analyten in einer körperflüssigkeit
EP23175596.8A Active EP4233719B1 (de) 2016-02-05 2016-02-05 Medizinische vorrichtung zur detektion von mindestens einem analyten in einer körperflüssigkeit

Family Applications Before (3)

Application Number Title Priority Date Filing Date
EP21175139.1A Active EP3909506B1 (de) 2016-02-05 2016-02-05 Medizinische vorrichtung zur detektion von mindestens einem analyten in einer körperflüssigkeit
EP16154468.9A Active EP3202323B1 (de) 2016-02-05 2016-02-05 Medizinische vorrichtung zur detektion von mindestens einem analyten in einer körperflüssigkeit
EP23175609.9A Active EP4233721B1 (de) 2016-02-05 2016-02-05 Medizinische vorrichtung zur detektion von mindestens einem analyten in einer körperflüssigkeit

Family Applications After (1)

Application Number Title Priority Date Filing Date
EP23175596.8A Active EP4233719B1 (de) 2016-02-05 2016-02-05 Medizinische vorrichtung zur detektion von mindestens einem analyten in einer körperflüssigkeit

Country Status (15)

Country Link
US (6) US11759132B2 (de)
EP (5) EP3909506B1 (de)
CN (1) CN108601564B (de)
CY (1) CY1126120T1 (de)
DK (4) DK4233719T3 (de)
ES (2) ES2952014T3 (de)
FI (4) FI4233721T3 (de)
HR (1) HRP20230788T1 (de)
HU (2) HUE056062T2 (de)
LT (4) LT4233720T (de)
PL (1) PL3909506T3 (de)
PT (4) PT4233719T (de)
RS (1) RS64385B1 (de)
SI (1) SI3909506T1 (de)
WO (1) WO2017134211A1 (de)

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ES2903121T3 (es) 2016-02-05 2022-03-31 Hoffmann La Roche Dispositivo médico para detectar al menos un analito en un líquido corporal
US10182750B1 (en) * 2017-04-27 2019-01-22 Verily Life Sciences Llc Electrically-isolated and moisture-resistant designs for wearable devices
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US20220218240A1 (en) * 2019-08-19 2022-07-14 Medtrum Technologies Inc. Sensing device
CN113274001B (zh) * 2020-02-20 2023-07-25 上海移宇科技股份有限公司 分析物检测器件的安装单元及其安装方法
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